Associate Director Clinical Research & Develo

Overview

SUMMARY OF POSITION:
The successful candidate will help in the clinical development of 505(b)(2) products and complex generics. The candidate should be able to act as an independent clinical pharmacologist and will partner with formulation development, analytical chemistry, project management, and regulatory affairs to provide clinical strategies for internal and external R&D programs.

Reports to Senior Director, Clinical R&D and is based in Pine Brook, New Jersey.

• Assess viability of 505(b)(2) and complex generics ideas from the Clinical R&D perspective.
• Act as an independent clinical pharmacologist to identify required studies per regulatory strategy, and to design and execute such studies.
• Provide clinical expertise pertaining to study design, planning and execution of Phase 1, Phase 2 or Phase 3 clinical studies.
• Ensure each project has a robust PK and clinical program and adheres to GCP, GLP and all applicable regulatory guidelines. Monitor changes/updates to Guidance documents related to Clinical studies/BE studies and implement them.
• Identify gaps in pre-clinical and Phase 1 DDP that could impact Phase 2/3 design and execution timelines for internal projects and for due diligence programs.
• Draft initial pediatric study plan (iPSP) and clinical sections of regulatory submissions (e.g., pIND, Type A/B/C/D meetings, NDA) for 505(b)(2) products.
• Partner with Regulatory Affairs for FDA meetings to ensure successful execution of 505(b)(2) programs.
• Collaborate with R&D during product development to provide guidance on PK issues, biorelevant dissolution, PK modeling, simulations, Win Nonlin, and IVIVC/IVIVR models.
• Collaborate with Portfolio and Business Development to provide scientific feedback and clinical plans for identifying and developing new products through in-licensing or due diligence efforts.
• Work cross-functionally and with external partners to select clinical study designs that align with Company objectives; work with Regulatory in filing of applications and responding to deficiencies.

• Ph.D in a scientific discipline with at least 10 years of experience in the conduct of PK, clinical end point, and Phase 2/3 studies.
• Experience in generic/specialty pharmaceutical companies on a variety of dosage forms, including inhalation, topical, and complex injectable products.
• Clinical development experience with 505(b)(2) products is required. Experience in CNS/Psychiatric therapeutics (e.g., MDD, Schizophrenia) is preferred.
• Thorough knowledge of scientific principles applicable to product development and extensive experience in PK modeling, simulation, IVIVC/IVIVR to support product development.
• Extensive knowledge of clinical development, including understanding of the clinical development phases, processes and techniques used to execute a clinical development program.
• Knowledge of GCP, GLP, ICH and regulatory guidelines is essential.
• Excellent written and verbal communications and interpersonal skills.
• The following traits are essential for success:
  • Proven strong leadership and management skills; ability to work across a portfolio with competing priorities
  • Team player with proven flexibility; high degree of motivation
  • Self-starter; can work with limited direction
  • Strong analytical skills
  • Hands-on, "roll up your sleeves" and "right first time" mentality
  • Ability to think strategically and execute on strategy

This position needs to follow SOPs and alert QA of risks that could impact product safety and efficacy.

EOE/M/F/Vet/Disability